MSI Precision Specialty Instruments

Basic Information

• Brand Name: MSI Precision Specialty Instruments
• Primary DI: 00194613040109
• Version / Model: TONO TIP BULK
• Company Name: Med Saver, Inc.
• Labeler DUNS: 556623486
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 600
• Record Status: Published
• Publish Date: 2024-08-15
• Public Version: 2
• Public Version Date: 2025-07-30
• Public Version Status: Update
• Public Device Record Key: 618963c0-0efa-4fd2-affd-7d8ec0b1d98b

Device Description

Tono Pen Tip Covers, Sanitized Sleeve, Bulk, 600 Units Per Package

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HMR	Marker, ocular	Ophthalmic	886.4570	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63247	Surgical instrument guard, single-use	A device designed to be used with a surgical or invasive instrument to protect the instrument from damage and/or the operator or patient from injury. It is typically made of metal or plastic materials and available in a variety of designs. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10194613040106	GS1
Primary	00194613040109	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]